U.S. patent application number 12/450776 was filed with the patent office on 2011-02-24 for analyzing tool.
This patent application is currently assigned to ARKRAY, Inc. Invention is credited to Sadaaki Kimura, Yasuhide Kusaka.
Application Number | 20110042212 12/450776 |
Document ID | / |
Family ID | 39864018 |
Filed Date | 2011-02-24 |
United States Patent
Application |
20110042212 |
Kind Code |
A1 |
Kusaka; Yasuhide ; et
al. |
February 24, 2011 |
ANALYZING TOOL
Abstract
The present invention relates to an analyzing tool including: a
plurality of electrodes 10, 11 and 12 formed in an annular shape
with stacked on one another in an axial direction; and a specimen
layer formed in an interior of at least one of the plurality of
electrodes 10, 11 and 12. The analyzing tool according to the
present invention may be configured to include: a first electrode
formed in an annular shape; a second electrode formed in an annular
shape and inserted through an interior of the first electrode with
a space from an inner peripheral surface of the first electrode;
and a specimen layer formed between the inner peripheral surface of
the first electrode and an outer peripheral surface of the second
electrode.
Inventors: |
Kusaka; Yasuhide; (Kyoto,
JP) ; Kimura; Sadaaki; (Kyoto, JP) |
Correspondence
Address: |
RADER FISHMAN & GRAUER PLLC
LION BUILDING, 1233 20TH STREET N.W., SUITE 501
WASHINGTON
DC
20036
US
|
Assignee: |
ARKRAY, Inc
Kyoto
JP
|
Family ID: |
39864018 |
Appl. No.: |
12/450776 |
Filed: |
April 12, 2008 |
PCT Filed: |
April 12, 2008 |
PCT NO: |
PCT/JP2008/057218 |
371 Date: |
May 18, 2010 |
Current U.S.
Class: |
204/412 ;
204/400 |
Current CPC
Class: |
A61B 5/1519 20130101;
A61B 5/151 20130101; A61B 5/150618 20130101; A61B 2562/125
20130101; A61B 5/150274 20130101; A61B 5/150503 20130101; A61B
5/150564 20130101; A61B 5/150549 20130101; A61B 5/15117 20130101;
A61B 5/150412 20130101; A61B 5/14532 20130101; A61B 5/15194
20130101; A61B 5/1486 20130101; A61B 5/150702 20130101; A61B
5/150358 20130101; A61B 5/150213 20130101; A61B 5/15123 20130101;
A61B 2562/0295 20130101; A61B 5/14546 20130101; G01N 27/3271
20130101; C12Q 1/001 20130101; A61B 5/150022 20130101; A61B 5/15107
20130101 |
Class at
Publication: |
204/412 ;
204/400 |
International
Class: |
G01N 27/30 20060101
G01N027/30 |
Foreign Application Data
Date |
Code |
Application Number |
Apr 12, 2007 |
JP |
2007-105292 |
Claims
1. An analyzing tool comprising: a plurality of electrodes formed
in an annular shape with stacked on each other in an axial
direction; and a specimen layer formed in an interior of at least
one of the plurality of electrodes.
2. The analyzing tool as claimed in claim 1, wherein an insulation
layer is interposed between the adjacent electrodes in the
plurality of electrode.
3. The analyzing tool as claimed in claim 2, wherein the insulation
layer electrically joins the adjacent electrodes with each
other.
4. The analyzing tool as claimed in claim 1, wherein the adjacent
electrodes in the plurality of electrode are coupled with each
other by an insulation tube provided to mantle these electrodes
with a certain space therebetween.
5. The analyzing tool as claimed in claim 4, wherein the insulation
tube is a heat-shrinkable tube.
6. The analyzing tool as claimed in claim 1, further comprising a
sealing member for embracing outer peripheral surfaces of the
plurality of electrodes.
7. The analyzing tool as claimed in claim 6, wherein the sealing
member has through holes for exposing part of the outer peripheral
surfaces of the plurality of electrodes.
8. The analyzing tool as claimed in claim 1, wherein the plurality
of electrodes include a working electrode and a counter
electrode.
9. The analyzing tool as claimed in claim 8, wherein the plurality
of electrodes further include a detection electrode for detecting
supply of a specimen to interiors of these electrodes.
10. The analyzing tool as claimed in claim 1, wherein interiors of
the plurality of electrodes are configured to exert a capillary
force.
11. The analyzing tool as claimed in claim 1, wherein an insulation
layer is provided on an end surface of an outermost one in the
plurality of electrodes.
12. An analyzing tool comprising: a first electrode formed in an
annular shape; a second electrode formed in an annular shape and
inserted through an interior of the first electrode with a space
from an inner peripheral surface of the first electrode; and a
specimen layer formed between the inner peripheral surface of the
first electrode and an outer peripheral surface of the second
electrode.
13. The analyzing tool as claimed in claim 12, wherein an end
section of the second electrode projects from an end surface of the
first electrode.
14. The analyzing tool as claimed in claim 12, wherein an end
section of the second electrode is retracted behind an end surface
of the first electrode.
15. The analyzing tool as claimed in claim 12, wherein an end
section of the second electrode projects from an end surface of the
first electrode, and another end section of the second electrode is
retracted behind another end surface of the first electrode.
16. The analyzing tool as claimed in claim 12, wherein the first
electrode and the second electrode are joined with each other by an
adhesive, and the adhesive is supplied into through holes formed in
the first electrode and further adherently extended to an outer
peripheral surface of the second electrode.
17. The analyzing tool as claimed in claim 12, wherein the first
electrode is a working electrode, and the second electrode is a
counter electrode.
18. The analyzing tool as claimed in claim 17, wherein the specimen
layer is formed on an inner peripheral surface of the first
electrode.
19. The analyzing tool as claimed in claim 12, wherein a space
between the inner peripheral surface of the first electrode and the
outer peripheral surface of the second electrode is configured to
exert a capillary force.
20. The analyzing tool as claimed in claim 12, wherein at least one
of an end surface and an inner surface in a lower end section of
the second electrode is hydrophobized.
Description
TECHNICAL FIELD
[0001] The present invention relates to an analyzing tool used to
analyze a particular component (for example, glucose, cholesterol
or lactic acid) in a specimen (for example, biochemical specimen
such as blood or urine).
BACKGROUND ART
[0002] In the conventional methods for measuring a glucose
concentration in blood, a disposable analyzing tool is often used
for easy handling (for example, see the Patent Literature 1). An
example of the analyzing tool is adapted to measure a response
current value necessary for the calculation of a blood glucose
level using a working electrode 91 and a counter electrode 92
provided on a substrate 90 in a manner similar to a glucose sensor
9 illustrated in FIGS. 24 to 26. The glucose sensor 9 transfers
blood using a capillary force generated in a capillary 93 and
measures an amount of electrons transferred when the glucose in
blood and the specimen are reacted with each other as the response
current value in the working electrode 91. The capillary 93 is
formed by overlaying a cover 96 on the substrate 90 with a spacer
95 provided with a slit 94 interposed therebetween. The substrate
90 retains the specimen in a specimen portion 99 provided in an
opening 98 of an insulation film 97.
[0003] Patent Literature 1: Japanese Examined Patent KOKOKU
Publication No. H08-10208
DISCLOSURE OF INVENTION
Problem to be Solved by the Invention
[0004] A sensitivity of the glucose sensor 9 is variable depending
on an area on a part of the working electrode 91 exposed in the
capillary 93. On the contrary, it is difficult to secure a large
area for the working electrode 91 in a structure wherein the cover
96 overlays the substrate 90 with the spacer 95 interposed
therebetween and the working electrode 91 is provided on the
substrate 90. In order to reduce an amount of blood sampling, it is
necessary to downsize the glucose sensor 9 so that the capillary
has a smaller volume, nevertheless, a higher sensitivity is
demanded. All these facts inevitably make it difficult to ensure a
high sensitivity and also meet the demand for downsizing in the
glucose sensor 9.
[0005] A main object of the present invention is to provide an
analyzing tool capable of ensuring a high sensitivity while meeting
the demand for downsizing.
Means for Solving the Problem
[0006] A first aspect of the present invention provides an
analyzing tool including: a plurality of electrodes formed in an
annular shape with stacked on each other in an axial direction; and
a specimen layer formed in an interior of at least one of the
plurality of electrodes.
[0007] An insulation layer, for example, is interposed between the
adjacent electrodes in the plurality of electrode. The insulation
layer preferably joins the adjacent electrodes with each other.
[0008] The adjacent electrodes in the plurality of electrode may be
coupled with each other by an insulation tube provided to mantle
these electrodes with a certain space therebetween. The insulation
tube is preferably a heat-shrinkable tube.
[0009] The analyzing tool according to the present invention may
further include a sealing member for embracing outer peripheral
surfaces of the plurality of electrodes. The sealing member
preferably has through holes for exposing part of the outer
peripheral surfaces of the plurality of electrodes.
[0010] The plurality of electrodes include, for example, a working
electrode and a counter electrode. The plurality of electrodes may
further include a detection electrode for detecting the supply of a
specimen to the interiors of these electrodes.
[0011] The interiors of the plurality of electrodes are preferably
configured to exert a capillary force.
[0012] An insulation layer may be provided on an end surface of an
outermost one in the plurality of electrodes.
[0013] A second aspect of the present invention provides an
analyzing tool including: a first electrode formed in an annular
shape; a second electrode formed in an annular shape and inserted
through an interior of the first electrode with a space from an
inner peripheral surface of the first electrode; and a specimen
layer formed between the inner peripheral surface of the first
electrode and an outer peripheral surface of the second
electrode.
[0014] For example, an end section of the second electrode projects
from an end surface of the first electrode.
[0015] For example, an end section of the second electrode is
retracted behind an end surface of the first electrode.
[0016] Preferably, an end section of the second electrode projects
from an end surface of the first electrode, and another end section
of the second electrode is retracted behind another end surface of
the first electrode.
[0017] The first electrode and the second electrode are joined with
each other by, for example, an adhesive. The adhesive is preferably
supplied into through holes formed in the first electrode and
further adherently extended to an outer peripheral surface of the
second electrode.
[0018] Preferably, the first electrode is a working electrode, and
the second electrode is a counter electrode, in which case the
specimen layer is preferably formed on an inner peripheral surface
of the first electrode.
[0019] A space between the inner peripheral surface of the first
electrode and the outer peripheral surface of the second electrode
is, for example, configured to exert a capillary force.
[0020] At least one of an end surface and an inner surface in a
lower end section of the second electrode may be hydrophobized.
BRIEF DESCRIPTION OF DRAWINGS
[0021] FIG. 1 is an overall perspective view of a biosensor
according to a preferred embodiment 1 of the present invention.
[0022] FIG. 2 is a sectional view cut along II-II Line illustrated
in FIG. 1.
[0023] FIG. 3 is an overall perspective view illustrating another
example of the biosensor.
[0024] FIG. 4 is a perspective view for describing a method for
manufacturing the biosensor illustrated in FIG. 1.
[0025] FIG. 5 is a perspective view for describing the method for
manufacturing the biosensor illustrated in FIG. 1.
[0026] FIG. 6 is a perspective view for describing the method for
manufacturing the biosensor illustrated in FIG. 1.
[0027] FIG. 7 is a perspective view for describing the method for
manufacturing the biosensor illustrated in FIG. 1.
[0028] FIG. 8 is a perspective view for describing the method for
manufacturing the biosensor illustrated in FIG. 1.
[0029] FIG. 9 is a perspective view for describing the method for
manufacturing the biosensor illustrated in FIG. 1.
[0030] FIG. 10 is an overall perspective view of a biosensor
according to a preferred embodiment 2 of the present invention.
[0031] FIG. 11 is a sectional view cut along XI-VI Line illustrated
in FIG. 10.
[0032] FIG. 12 is a sectional view cut along XII-XII Line
illustrated in FIG. 10.
[0033] FIG. 13 is an overall perspective view of a biosensor
according to a preferred embodiment 3 of the present invention.
[0034] FIG. 14 is a sectional view cut along XIV-XIV Line
illustrated in FIG. 13.
[0035] FIG. 15 is an overall perspective view of a biosensor
according to a preferred embodiment 4 of the present invention.
[0036] FIG. 16 is a sectional view cut along XVI-XVI Line
illustrated in FIG. 15.
[0037] FIGS. 17A and 17B are perspective views for describing a
method for manufacturing the biosensor illustrated in FIG. 15.
[0038] FIG. 18 is a perspective view for describing the method for
manufacturing the biosensor illustrated in FIG. 15.
[0039] FIG. 19 is an overall perspective view illustrating a device
according to a preferred embodiment 5 of the present invention by
removing a part of the device.
[0040] FIG. 20 is a sectional view cut along XX-XX Line illustrated
in FIG. 19.
[0041] FIG. 21 is a sectional view illustrating a state where the
device of FIG. 19 is mounted in a puncture device.
[0042] FIGS. 22A and 22B are sectional views for describing
operations of the device illustrated in FIG. 19 and the puncture
device illustrated in FIG. 21.
[0043] FIG. 23 is a sectional view for describing the operations of
the device illustrated in FIG. 19 and the puncture device
illustrated in FIG. 21.
[0044] FIG. 24 is an overall perspective view illustrating a
conventional biosensor.
[0045] FIG. 25 is a sectional view cut along XXV-XXV Line
illustrated in FIG. 24.
[0046] FIG. 26 is an exploded perspective view of the biosensor
illustrated in FIG. 24.
EXPLANATION OF REFERENCE NUMERALS
[0047] 1, 1': biosensor (analyzing tool)
[0048] 10: working electrode
[0049] 11: counter electrode
[0050] 12: detection electrode
[0051] 14: specimen layer
[0052] 15, 16: insulation layer
[0053] 3: biosensor
[0054] 31: sealing member
[0055] 32, 33, 34: contact hole (through hole)
[0056] 4: biosensor (analyzing tool)
[0057] 42, 43: (insulation) tube
[0058] 5: biosensor
[0059] 50: working electrode (first electrode)
[0060] 50b: end surface (one end surface) (of working
electrode)
[0061] 50c: end surface (another end surface) (of working
electrode)
[0062] 51: counter electrode (second electrode)
[0063] 51a: outer peripheral surface (of counter electrode)
[0064] 52: specimen layer
[0065] 53: through hole
[0066] 54: adhesive
[0067] 56: upper end section (one end section) (of counter
electrode)
[0068] 57: lower end section (another end section) (of counter
electrode)
BEST MODE FOR CARRYING OUT THE INVENTION
[0069] Hereinafter, preferred embodiments 1 to 5 of the present
invention are described referring to the drawings.
[0070] First, the preferred embodiment 1 is described referring to
FIGS. 1 to 9.
[0071] A biosensor 1 illustrated in FIGS. 1 and 2 is configured to
be disposable, and an overall shape thereof is a cylindrical shape.
The biosensor 1 is loaded in a device (not shown) having an
analyzing function such as a concentration measurement device to be
used to analyze a particular component (for example, glucose,
cholesterol or lactic acid) in a specimen (for example, biochemical
specimen such as blood or urine). The biosensor 1 includes a
working electrode 10, a counter electrode 11, a detection electrode
12, a capillary 13, and a specimen layer 14.
[0072] The working electrode 10 and the counter electrode 11 apply
a voltage to the specimen introduced into the capillary 13 and also
used to measure a response current generated then. The detection
electrode 12 is used to detect whether or not the capillary 13 has
been supplied with a predetermined amount of specimen.
[0073] The working electrode 10, the counter electrode 11 and the
detection electrode 12 are formed in an annular shape having equal
or substantially equal outer and inner diameters. The working
electrode 10, the counter electrode 11 and the detection electrode
12 are stacked on one another in an axial direction in this order
so that axial centers of these electrodes coincide or substantially
coincide with one another. The working electrode 10, the counter
electrode 11 and the detection electrode 12 are made of, for
example, nickel, iron, copper, alloy obtained from these metals,
stainless steel or carbon, and formed so as to have an outer
diameter of 0.5 to 2.0 mm, an inner diameter of 0.2 to 1.6 mm, and
an axial dimension of 1.0 to 5.0 mm.
[0074] The working electrode 10, the counter electrode 11 and the
detection electrode 12 are not necessarily provided in the order
illustrated in the drawing but may be differently ordered. The
detection electrode 12 may be omitted, and two electrodes, that are
the working electrode 10 and the counter electrode 11, alone may be
used.
[0075] The working electrode 10 and the counter electrode 11, and
the counter electrode 11 and the detection electrode 12 are joined
with each other with adhesive layers 15 and 16 having insulation
properties, respectively. The adhesive layers 15 and 16 may be
wholly made of an adhesive material, or may be a medium provided
with the adhesive material on both surfaces thereof. Examples of
the adhesive material usable for the adhesive layers 15 and 16 are
synthetic adhesives such as: thermosetting resin (for example, urea
resin, melamine resin, resorcinol resin, phenol resin, epoxy resin,
polyurethane resin, polyaromatic resin or polyester resin); and
thermoplastic resin (for example, vinyl acetate resin,
polyvinylalcohol resin, polyvinylacetal resin, polyvinyl resin,
acrylic resin, polyethylene resin or cellulose resin); elastomeric
adhesive (chloroprene rubber adhesive, nitrile rubber adhesive, SBR
adhesive, SBR-SIS adhesive, polysulfide rubber adhesive, butyl
rubber adhesive, or silicone rubber adhesive). A particularly
preferable example of the adhesive is an epoxy resin adhesive
superior in its adhesive strength such as EPDXY REIN XNR 3506
(manufactured by Nagase ChemteX Corporation) OR EPDXY REXIN XNR
3501 (manufactured by Nagase ChemteX Corporation).
[0076] An insulation layer 17 is formed on an end surface 10a of
the working electrode 10. The insulation layer 17 is provided to
prevent the specimen from sticking to an outer peripheral surface
of the working electrode 10. A structure of and a material for the
insulation layer 17 may be similar to those of the adhesive layers
15 and 16.
[0077] The capillary 13 transfers the specimen introduced through
an opening 13a toward an opening 13b utilizing capillarity and then
retains the introduced specimen. The capillarity 13 is defined by
inner surfaces of the working electrode 10, counter electrode 11,
detection electrode 12 and adhesive layers 15 and 16, and its
volume is set to, for example, 0.03 to 10 [micro]L.
[0078] The specimen layer 14 is provided so as to bridge the
working electrode 10, the counter electrode 10 and the detection
electrode 12 in the capillary 13. The specimen layer 14 includes an
electron transmitter and oxidoreductase and is formed in such a
solid shape that is easily dissolved when making contact with the
specimen. Therefore, when the specimen is introduced into the
capillary 13, the specimen layer 14 is dissolved, and a liquid
phase reaction system including the electron transmitter,
oxidoreductase and specimen is built in the capillary 13.
[0079] The selection of the oxidoreductase depends on the type of
the particular component to be analyzed. When the glucose, for
example, is analyzed, glucose hydrogenase (GDH) or glucose oxidase
(GOD) can be used. Examples of the electron transmitter are
ruthenium complex and iron complex, and [Ru(NH3)6]Cl3 or
K3[Fe(CN)6] can be typically used.
[0080] The specimen layer 14 is provided so as to bridge the
working electrode 10, the counter electrode 11 and the detection
electrode 12 in the illustrated example. The specimen layer 14 may
be differently formed as far as at least the inner surface of the
working electrode 10 can be thereby covered.
[0081] In the biosensor 1, the working electrode 10 is
cylindrically formed, electrons can be transferred to and from the
electron transmitter on an entire area of an inner surface 10b
thereof. Accordingly, the biosensor 1 can reliably acquire a larger
electron receiving surface (inner surface 10b) in the working
electrode 10 than in the conventional biosensor 9 having a plate
shape wherein the working electrode 91 is formed in a shape of a
film on the substrate 90 (see FIGS. 24 to 26). Further, a planar
dimension of the electron receiving surface (inner surface 10b) in
the working electrode 10 can be easily adjusted according to an
inner diameter and a height dimension of the working electrode. In
a case where the biosensor 1 is downsized, therefore, the electron
receiving surface (inner surface 10b) of the working electrode 10
per unit volume of the capillary 13 can be fairly large when the
inner diameter and the height dimension of the working electrode 10
are suitably set. As a result, the biosensor 1, though downsized,
can reliably achieve a high sensitivity.
[0082] The biosensor 1 illustrated in FIGS. 1 and 2 is overall
cylindrically shaped. The shape, however, may be a cube shape as in
a biosensor 1' illustrated in FIG. 3. In FIG. 3, any structural
elements similar to those of the biosensor 1 illustrated in FIGS. 1
and 2 are shown with the same reference symbols attached
thereto.
[0083] Next, a method for manufacturing the biosensor 1 is
described referring to FIGS. 4 to 9.
[0084] As illustrated in FIGS. 4 and 5, a double-stick adhesive
sheet 21 having insulation properties is bonded to a metal plate 20
so that a laminated plate 22 is formed. An example of the metal
plate 20 is a plate made of nickel, iron, copper, alloys obtained
from these metals, stainless steel or carbon and formed in a
thickness of 0.1 to 2.0 mm. An example of the double-stick adhesive
sheet 21 is a sheet having a thickness of 0.015 to 0.5 mm obtained
by forming an adhesive layer made of acrylic resin, silicone resin
or the like on both surfaces of a medium such as a polyester film.
As the double-stick adhesive sheet 21 may be used a simple adhesive
layer in which no medium is used.
[0085] As illustrated in FIGS. 6 and 7, three laminated plates 22
are bonded to one another so that the respective double-stick
adhesive sheets 21 are sandwiched with the metal plates 20
interposed therebetween, so that a multilayered product 23 is
formed.
[0086] In a case where the detection electrode 12 is omitted in the
biosensor 1, two laminated plates 22 are bonded to each other to
constitute the multilayered product 23.
[0087] Then, a plurality of through holes 24 are formed in a matrix
shape in the multilayered product 23 as illustrated in FIG. 8. The
through hole 24 is formed by drilling, punching or laser processing
in a columnar shape having a diameter of 0.3 to 2.0 mm and a volume
of 0.05 to 10 [micro]L.
[0088] As illustrated in FIG. 9, a specimen-containing agent in
liquid or slurry state is applied to the plurality of through holes
24. After the specimen-containing agent is applied to the through
holes 24, the specimen-containing agent is sucked into the through
holes 24 by the capillarity generated in the through holes 24. A
conventional dispenser can be used for the application of the
specimen-containing agent. The specimen-containing agent includes,
for example, oxidoreductase suitable for the particular component
to be analyzed and the electron transmitter such as ruthenium
complex or iron complex.
[0089] When interiors of the plurality of through holes 24 are
filled with the specimen-containing agent, moisture in the
specimen-containing agent is evaporated by heating or the like, and
the specimen in solid state is thereby attached to inner surfaces
of the through holes 24 (see FIG. 2). In a case where the
specimen-containing agent includes oxidoreductase, it is necessary
to heat the specimen-containing agent in such a manner that the
enzyme is neither deactivated nor modified.
[0090] Finally, the multilayered product 23 is subject to
die-cutting on the periphery of the through hole 24. As a result,
the cylindrical biosensor 1 illustrated in FIGS. 1 and 2 can be
obtained. When the multilayered product 23 is cut longitudinally
and laterally between the plurality of through holes 23, the
cube-shape biosensor 1' illustrated in FIG. 3 can be obtained.
[0091] As described, the biosensors 1 and 1' are capable of
ensuring a high sensitivity while meeting the demand for
downsizing, and can be advantageously manufactured in such a
simplified process.
[0092] A preferred embodiment 2 of the present invention is
described below referring to FIGS. 10 to 12. In FIGS. 10 to 12, any
structural elements similar to those of the biosensor 1 described
earlier referring to FIGS. 1 and 2 are shown with the same
reference symbols attached thereto, and the description of these
structural elements will not be given.
[0093] A biosensor 3 illustrated in FIGS. 10 to 12 includes a
sensor body 30 and a sealing member 31.
[0094] The sensor body 30 corresponds to the biosensor 1
illustrated in FIGS. 1 and 2.
[0095] The sealing member 31 protects the sensor body 30 and also
improves handle-ability of the biosensor 3. The sealing member 31
is formed by resin molding using thermoplastic resin such as acryl,
nylon or polyacetate or thermosetting resin such as epoxy resin or
polyester resin so as to embrace an outer peripheral surface of the
sensor body 30. The sealing member 31 is provided with three
contact holes 32, 33 and 34. The contact holes 32 to 34 are
provided to allow an external connector (not shown) to be brought
in contact with the working electrode 10, the counting electrode 11
and the detection electrode 12 in the sensor body 30. The contact
holes 32 to 34 are formed so as to expose part of the outer
peripheral surfaces of the working electrode 10, the counter
electrode 11 and the detection electrode 12.
[0096] The handle-ability of the biosensor 3 thus constituted can
be improved by the sealing member 31 as described earlier. The
biosensor 3 is further advantageous in a case where a plurality of
biosensors 3 are aligned and housed in the form of a cartridge.
[0097] In the biosensor 3, the device body 30 corresponding to the
biosensor 1 illustrated in FIGS. 1 and 2 is used, so that a
manufacturing process can be simplified and a high sensitivity can
be reliably attained.
[0098] It is needless to say that the cube-shape biosensor 1'
illustrated in FIG. 3 can be used as the sensor body 30.
[0099] A preferred embodiment 3 of the present invention is
described below referring to FIGS. 13 and 14. In FIGS. 13 and 14,
any structural elements similar to those of the biosensor 1
described earlier referring to FIGS. 1 and 2 are shown with the
same reference symbols attached thereto, and the description of
these structural elements will not be given.
[0100] A biosensor 4 illustrated in FIGS. 13 and 14 includes a
working electrode 10, a counter electrode 11 and a detection
electrode 12. These electrodes are coupled with each other in an
axial direction by tubes 42 and 43, respectively, with spaces 40
and 41 provided therebetween.
[0101] The tubes 42 and 43 have insulation properties. The tubers
42 and 43 couple the two adjacent electrodes 10 and 11 (11 and 12)
with each other in a state where they mantle the electrodes 10 and
11 (11 and 12). The electrodes 10 to 12 are electrically isolated
from one another because the tubes 42 and 43 have insulation
properties and the spaces 40 and 41 are provided between the
respective electrodes 10 to 12.
[0102] A heat-shrinkable product can be used as the tubes 42 and
43. The heat-shrinkable tubes 42 and 43 can be made of, for
example, silicone rubber, ethylene propylene rubber, polyvinyl
chloride, elastic neoprene, polyimide or fluororesin).
[0103] When the electrodes 10 and 11 (11 and 12) are coupled with
each other by the heat-shrinkable tubes 42, 43, the electrodes 10
and 11 (11 and 12) are placed on each other with the space 40, 41
interposed therebetween, and the tubes 42, 43 are heated to be
shrunk after the adjacent electrodes 10 and 11 (11 and 12) are
mantled by the tubes 42, 43. The coupling method thus constituted
can be very easily performed, which advantageously facilitates the
manufacturing of the biosensor 4.
[0104] The working electrode 10, the counter electrode 11 and the
detection electrode 12 are not necessarily provided in the
biosensor 4 in the order illustrated in the drawing but may be
differently ordered. The detection electrode 12 may be omitted, and
two electrodes, that are the working electrode and the counter
electrode 11, alone may be used.
[0105] Next, a preferred embodiment 4 of the present invention is
described referring to FIGS. 15 to 18.
[0106] A biosensor 5 illustrated in FIGS. 15 and 16 includes a
working electrode 50, a counter electrode 51 and a specimen layer
52.
[0107] The working electrode 50 is formed in an annular shape
having an inner diameter larger than an outer diameter of the
counter electrode 51, and accordingly mantles the counter electrode
51. The working electrode 50 is formed so as to have such
dimensions as an outer diameter of 2.0 to 5.0 mm, an inner diameter
of 1.0 to 4.5 mm, and an axial dimension of 1.0 to 5.0 mm. The
working electrode 50 has a plurality of through holes 53, and
supports the counter electrode 51 by means of these through holes
53. More specifically, the plurality of through holes 53 are filled
with an adhesive 54 having insulation properties, and part of the
adhesive 54 further extends to an outer peripheral surface 51a of
the counter electrode 51, so that the counter electrode 51 is
supported by the working electrode 50. An inner diameter of the
through hole 53 is set to, for example, 0.1 to 1.0 mm.
[0108] The counter electrode 51 has an annular shape, and is
supported by the working electrode 50 with inserted through an
interior of the working electrode 50. The counter electrode 51 has
such dimensions as an outer diameter of 0.8 to 4.5 mm, an inner
diameter of 0.5 to 4.0 mm, and an axial dimension of 1.0 to 10
mm.
[0109] Because the working electrode 50 is formed in such an
annular shape that has the inner diameter larger than the outer
diameter of the counter electrode 51, a space 55 is formed between
the outer peripheral surface 51a of the counter electrode 51 and an
inner surface 50a of the working electrode 50. The space 55 serves
as a capillary which exerts a capillary force to thereby introduce
the specimen thereinto. An upper end section 56 of the counter
electrode 51 projects from an end surface 50b of the working
electrode 50, and a lower end section 57 thereof is retracted
behind an end surface 50c of the working electrode 50. At least one
of an end surface 51c and an inner surface 51d of the lower end
section 57 in the counter electrode 51 may be hydrophobized. Any of
the various conventional treatments can be employed to hydrophobize
these surfaces, for example, the surfaces can be coated with
hydrophobic resin such as a fluorine compound.
[0110] The specimen layer 52 is constituted in a manner similar to
the specimen layer 14 in the biosensor 1 descried earlier (see FIG.
2). The specimen layer 52 is formed on the inner surface 50a of the
working electrode 50 to be present in the space 55. The space 55 is
used to introduce the specimen as described earlier, therefore, the
specimen layer 52 is dissolved by the specimen introduced into the
space 55.
[0111] As far as the specimen layer 52 is present in the space 55,
the location of the specimen layer 52 is not necessarily limited to
the inner surface 50a of the working electrode 50 but may be the
outer peripheral surface 51a of the counter electrode 51.
[0112] In the biosensor 5, the working electrode 50 is
cylindrically formed, electrons can be transferred to and from the
electron transmitter in an entire area of the inner surface 50a
thereof. Accordingly, the biosensor 1 can reliably acquire a larger
electron receiving surface (inner surface 50a) in the working
electrode 50 than in the conventional biosensor 9 having a plate
shape wherein the working electrode 91 is formed in a shape of a
film on the substrate 90 (see FIGS. 24 to 26). Further, with the
working electrode 50 mantling the counter electrode 51, the
electron receiving surface (inner surface 50a) can be further
increased as compared with a structure wherein the working
electrode 50 and the counter electrode 51 are axially coupled with
each other. In a case where the biosensor 1 is downsized, the
electron receiving surface (inner surface 50a) of the working
electrode 50 per unit volume of the capillary (space 55) can still
be fairly large. As a result, the biosensor 5, though downsized,
can ensure a high sensitivity.
[0113] In the biosensor 5, the upper end section 56 of the counter
electrode 51 projects from the end surface 50b of the working
electrode 50, a contact point between an external connector (not
shown) and the counter electrode 51 can be easily obtained.
Further, in the biosensor 5, the lower end section 57 of the
counter electrode 51 is retracted behind the end surface 50c of the
working electrode 50, the specimen can be prevented from entering
an interior 59 of the counter electrode 51 when the specimen is
attached to the lower end section 58 of the biosensor 5. When the
end surface 51c of the counter electrode 51 and the inner surface
51d of the lower end section 57 are hydrophobized, the specimen can
be more effectively prevented from entering the interior 58 of the
counter electrode 51.
[0114] Next, a method for manufacturing the biosensor 5 is
described.
[0115] First, a specimen layer 62 is formed on an inner surface 61
of a tube 60 having a large diameter as illustrated in FIG. 17A.
The specimen layer 62 can be formed by filling an interior of the
tube 60 with the specimen-containing agent and then evaporating
moisture in the specimen-containing agent.
[0116] Next, a plurality of through holes 63 are formed at
predetermined positions in the tube 60 as illustrated in FIG. 17B.
The through holes 63 are formed by laser processing or
die-cutting.
[0117] Then, a tube 64 having a small diameter and a predetermined
length is inserted through the interior of the tube 60 as
illustrated in FIG. 18. The tube 64 is inserted so that an end
section 65 of the tube 64 projects from an end surface 66 of the
tube 64. An adhesive 67, such as resin, is supplied into the
through holes 63 of the tube 60. An amount of the adhesive 67 to be
supplied is preferably larger than a volume of the through hole 63
because, accordingly, the adhesive 67 can fill the through holes
while being attached to an outer surface 68 of the tube 64. After
the supply of the adhesive 67 to the through holes 63, the adhesive
67 is cured.
[0118] Finally, the tubes 60 and 64 are cut along a cutting plane
line 69 shown with a dotted line in FIG. 18 after the adhesive 67
is cured. As a result, the biosensor 5 illustrated in FIGS. 15 and
16 can be obtained. The cutting plane line 69 is set so that the
lower end section 57 of the counter electrode 51 can be retracted
behind the end surface 50c of the working electrode 50 (see FIG.
16).
[0119] The biosensor 5 thus constituted makes it unnecessary to
form electrodes by, for example, screen printing, and can be
thereby easily and inexpensively manufactured.
[0120] In the biosensor 5, it is a selectable matter whether the
upper end section 56 of the counter electrode 51 projects from the
end surface 50b of the working electrode 50 or the lower end
section 57 of the counter electrode 51 is retracted behind the end
surface 50c of the working electrode 50. Further, the inner tube
may be used as a working electrode, and the outer tube may be used
as a counter electrode. The biosensor 5 may have its periphery
sealed with, for example, resin in the same manner as the biosensor
3 described referring to FIGS. 10 to 12.
[0121] Next, a preferred embodiment 5 of the present invention is
described referring to FIGS. 19 to 23. In FIGS. 19 to 23, any
structural elements similar to those of the biosensor 1 described
earlier referring to FIGS. 1 and 2 are shown with the same
reference symbols attached thereto, and the description of these
structural elements will not be given.
[0122] A device 7 illustrated in FIGS. 19 and 20 retains a
biosensor 71 and a lancet 72 in a case 70.
[0123] The case 70 is formed in a cylindrical shape in which an
upper portion is open, and a lower part is provided with a bottom
wall 73. The case 70 includes two retainers 75 and 76 provided at
positions offset by a substantially equal distance from a center 74
of the bottom wall 73. The retainer 75 is provided to retain the
biosensor 71, while the retainer 76 is provided to retain the
lancet 72. A bottom section 75A of the retainer 75 is provided with
a through hole 75B. The through hole 75B allows a puncture needle
72b of the lancet 72, described later, to pass therethrough, and
communicates with an interior of the biosensor 71.
[0124] The biosensor 71 is constituted in a manner similar to the
biosensor 1 described earlier referring to FIGS. 1 and 2, and
retained in the retainer 75 so that the working electrode 10 is
located downside. As a matter of course, the biosensor 1' described
referring to FIG. 3 and the biosensor 5 described referring to
FIGS. 15 and 16 can be used as the biosensor 71.
[0125] The lancet 72 is provided to incise a body part to be
punctured such as skin, and includes a columnar portion 72a, a
puncture needle 72b and a cap 72c. The columnar portion 72a is
mounted in a lancet holder 81 (see FIG. 21) of a puncture device 8
described later, and serves to retain the puncture needle 72b. The
puncture needle 72b is punctured into skin, and a top section 72d
thereof projects from the columnar portion 72a. The cap 72c covers
the top section 72d of the puncture needle 72b. A fragile portion
72e is provided between the cap 72c and the columnar portion 72a.
The fragile portion 72e is formed in the lancet 72 to make it
easier to wring the cap 72c off. In resin molding, the fragile
portion 72e is formed between the columnar portion 72a and the cap
72c, and the puncture needle 72b is inserted therethrough, so that
the lancet 72 is obtained.
[0126] As illustrated in FIG. 21, the device 7 is mounted at a top
section 80 of a puncture device 8 to be used. The puncture device 8
includes a lancet holder 81 and a connector 82.
[0127] The lancet holder 81 includes a recessed portion 83 for
retaining the columnar portion 72a of the lancet 72, and is allowed
to reciprocate upward and downward by a drive mechanism not shown.
Examples of the drive mechanism are a latch mechanism in which
springs are used, and a mechanism utilizing a motor rotational
force, magnetic force or electromagnetic force.
[0128] The connector 82 applies a voltage to between the working
electrode 10 and the counter electrode 11, or between the working
electrode 10 (counter electrode 11) and the detection electrode 12,
and measures a current between the electrodes 10 to 12. The
connector 82 includes contact points 84, 85 and 86 to be brought in
contact with the working electrode 10, the counter electrode 11 and
the detection electrode 12. The contact points 84 to 86 are
provided on a movement locus of the biosensor 7 when the case 70 is
rotated on the center of the bottom wall 73.
[0129] Next are described puncture and analysis operations in which
the device 7 and the puncture device 8 are used.
[0130] First, the device 7 is loaded in the puncture device 8 in a
state where the lancet 72 is position-adjusted to the lancet holder
81 as illustrated in FIG. 21. Accordingly, the columnar portion 72a
of the lancet 72 is fitted into the recessed portion 82 of the
lancet holder 81. When the lancet 72 is position-adjusted to the
lancet holder 81, for example, a protruding portion and a recessed
portion to be meshed with each other are provided at end sections
of the case 70 and the puncture device 8, and the device 7 is
loaded in the puncture device 8 so that the protruding portions and
the recessed portions are meshed with each other.
[0131] Next, the lancet holder 81 is moved upward and rotated at
the same time as illustrated in FIG. 22A. Accordingly, the lancet
72 is subject to a force which wrings the cap 72c off and a force
which pulls out the top section 72d of the puncture needle 72b from
the cap 72c. As a result, the cap 72c has been removed and the top
section 72d of the puncture needle 72b is exposed in the lancet
72.
[0132] The device 7 is rotated manually or automatically by a
rotary mechanism provided in the puncture device 8, and halted when
the lancet 72 is located immediately above the biosensor 71. Since
the connector 82 is placed on the rotation locus of the biosensor
71 as described earlier, the contact points 84 to 86 are brought in
contact with the working electrode 10, the counter electrode 11 and
the detection electrode 12 in the biosensor 71.
[0133] As illustrated in FIG. 22B, the lancet holder 81 is moved
downward by the drive mechanism, not shown, with the device 7
brought in contact with the part to be punctured such as skin.
Then, the lancet 72 is inserted into the biosensor 71, and the
puncture needle 72b is punctured through the part to be punctured.
As a result, the part to be punctured, such as skin, is
incised.
[0134] As illustrated in FIG. 23, the lancet holder 81 is moved
upward so that the puncture needle 72b is pulled out from the
punctured part. As a result, such a specimen as blood or
interstitial fluid flows out from the punctured part and is sucked
into the capillary 13 of the biosensor 71. In the capillary 13, the
specimen layer 14 is dissolved by the specimen such as blood, and a
liquid phase reaction system is thereby built in the capillary
13.
[0135] In the puncture device 8, it is confirmed if there is a flow
of liquid junction current between the working electrode 10 (or
counter electrode 11) and the detection electrode 12. Further, the
puncture device 8 is subject to voltage application by way of the
working electrode 10 and the counter electrode 11 so that a
response current value at the time of the voltage application is
measured.
[0136] In the liquid phase reaction system, oxidoreductase, for
example, specifically reacts with a particular component in the
specimen such as blood, and electrons are removed from the
particular component. Then, the electrons are supplied to the
electron transmitter, and the electron transmitter is converted to
a reduced electron transmitter. When the voltage is applied to the
liquid phase reaction system by means of the working electrode 10
and the counter electrode 11, the electrons are supplied to the
working electrode 10 from the reduced electron transmitter.
Therefore, the puncture device 8 can measure an amount of the
electrons supplied to the working electrode 10 as the response
current value. In the puncture device 8, a concentration of the
particular component, for example, glucose, is calculated based on
the response current value measured after a certain amount of time
has passed since the supply of blood to the capillary 13.
* * * * *